Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections

FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical